Prophylactic Negative Wound Therapy in Laparotomy Wounds. (PROPEL)

St. James's Hospital, Ireland

Status: Unknown

Conditions: Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay

Treatments: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing; Device: PREVENA Negative pressure wound versus standard dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03871023

SJH0519

Details and patient eligibility

About

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.

The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.

Full description

In the era of enhanced recovery, improving modifiable peri-operative and post-operative factors is essential to better patient outcomes. Surgical site complications in the form of wound infections are a major burden to the healthcare system. Negative pressure wound therapy (NPWT) as delivered by a surgical incision management system (SIMS) is a novel approach to improve wound healing when applied to closed incisions.

However, data is limited in its application to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.

In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc, surgical site complications continue to represent a huge healthcare burden.

Aim;

1. To determine if prophylactic negative pressure wound therapy confers a lower rate of Superficial Site Infection or reduces wound complications in Emergency or Elective Laparotomy wounds thereby improving post-operative patient recovery and reducing healthcare costs.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.

Exclusion criteria

• Pregnant patients and those undergoing re-look laparotomies are to be excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 3 patient groups

Simple dressing

Active Comparator group

Description:

Standard, waterproof dressing applied to wound

Treatment:

Device: PREVENA Negative pressure wound versus standard dressing

Device: Smith & Nephew PICO Negative wound pressure versus standard dresing

PICO Dressing

Active Comparator group

Description:

Negative Wound pressure applied second cohort

Treatment:

Device: PREVENA Negative pressure wound versus standard dressing

PREVENA Dressing

Active Comparator group

Description:

Negative wound presure applied to third cohort

Treatment:

Device: Smith & Nephew PICO Negative wound pressure versus standard dresing